RD SET™ Pdt SpO2, PR, PI, PVI® Pediatric Pulse Oximeter Adhesive Sensor 4001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10843997009574), received between Jul 8, 2017 and Dec 1, 2017 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Stops Intermittently” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2017Device Stops Intermittently; Device Stops Intermittently

  IT WAS REPORTED THE SENSORS STOP WORKING. SOMETIMES THEY LAST ONLY 1 HOUR AND SOMETIMES 24 HOURS. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7075434 ↗
• MalfunctionDec 1, 2017Device Stops Intermittently; Device Stops Intermittently

  IT WAS REPORTED THE SENSORS STOP WORKING. SOMETIMES THEY LAST ONLY 1 HOUR AND SOMETIMES 24 HOURS. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7075419 ↗
• MalfunctionDec 1, 2017Device Stops Intermittently; Device Stops Intermittently

  IT WAS REPORTED THE SENSORS STOP WORKING. SOMETIMES THEY LAST ONLY 1 HOUR AND SOMETIMES 24 HOURS. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7075402 ↗
• MalfunctionJul 16, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED THE NEW SENSORS HAD A HIGH FAILURE RATE OUT OF THE BOX AND INTERMITTENT FAILURE AFTERWARDS, THE RED LIGHT WOULD NOT LIGHT UP OR WOULD NOT STAY ON. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6716542 ↗
• MalfunctionJul 8, 2017Device Stops Intermittently; Device Operates Differently Than Expected; Device Stops Intermittently; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING SIGNAL LOSS DURING MONITORING. PER THE REPORT: CONTACTED BY (B)(6) IN BIO-MED THAT THE OR DEPT. WAS EXPERIENCING SIGNAL LOSS DURING CASES IN THE OR. STAFF HAD DISCONNECTED CABLES & SENSOR AND IT BEGAN TO WORK. I WENT IN TODAY AND WE STARTED WITH THE SENSOR AND IT WASN'T WORKING, CHANGED OUT THE SENSOR AND IT BEGAN TO WORK. I HAVE COLLECTED THAT SENSOR AND INSTRUCTED THEM TO HOLD ONTO ANY OTHERS THAT QUIT WORKING. IF THEY CHANGE SENSOR AND IT STILL DOESN'T WORK ALSO LEFT RD ADAPTER CABLE REPLACEMENT. THESE ARE DRAEGER DELTA ANESTHESIA MONITORS WITH MASIMO MODULE, RD ADAPTER CABLES USING ADULT & INFANT DISPOSABLE RD SENSORS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6695840 ↗